National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/hsdb-68603-42-9

CAS Registry Number: 68603-42-9 Toxicity Effects

Selected toxicity information from HSDB, one of the National Library of Medicine's databases. 1

Names (NTP)

  • Coconut oil acid diethanolamine condensate
  • COCONUT OIL ACID/DIETHANOLAMINE CONDENSATE
  • AMIDES,COCO,N,N-BIS(HYDROXYETHYL) (9CI)
  • COCONUT OIL ACID DIETHANOLAMINE CONDENSATE (TRANSGENIC LECM)
  • TRANSGENIC-LABORATORY OF ENVIRONMENTAL CARCINOGENESIS & MUTAGENESIS (COCONUT OIL ACID DIETHANOLAMINE CONDENSATE)
  • COCONUT OIL ACID DIETHANOLAMINE CON(2/1)
  • COCONUT OIL ACID/DIETHANOLAMINE CONDENSATE
  • COCONUT DIETHANOLAMIDE
  • COCONUT OIL ACID DIETHANOLAMINE CON(2/1)
  • COCONUT DIETHANOLAMIDE
  • AMIDES,COCO,N,N-BIS(HYDROXYETHYL) (9CI)
  • Transgenic LECM (Coconut oil acid diethanolamine condensate)

Human Toxicity Excerpts

  • HUMAN EXPOSURE STUDIES: One hundred four women participated in an in-use study to determine the safety and efficacy of a shampoo containing 2% cocamide DEA. Each panelist was patch tested on the upper arm with 2% aqueous shampoo, 15 ppm (in water) of the shampoo's preservative system, and 5% shampoo fragrance in mineral oil. The three occlusive patches were applied and scored for irritation 48 hr later at the time of patch removal. The subjects were then instructed to shampoo daily with the test product for 87 days. Ten days after the final use of the shampoo, challenge patches were administered following the same procedure as the initial patches except the preservative concentration was increased to 50 ppm and an additional scoring for reactions was made 24 hr after patch removal. No reactions were observed to the preservative or fragrance patches. Eleven subjects reacted to the 2% shampoo initial patch; eight had mild erythema (1+ scores on a 0 to 4 scale), one had intense erythema (2+), and two subjects had erythema and edema (3+). Twenty-four subjects had irritation scores of 1+ (18/24), 2+ (3/24), and 3+ (3/24) 48 hr after challenge patch application of the shampoo. Thirty subjects had 1+ (25/30) or 2+ (5/30) irritation scores at the second challenge reading. All reactions were considered to be irritant in nature. The shampoo was an irritant, but not a sensitizer.[Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleanmide DEA, and Oleamide DEA; Journal of American College of Toxicology 5 (5): 415-54 (1986)] **PEER REVIEWED**
  • HUMAN EXPOSURE STUDIES: Six allergic contact dermatitis patients, three of whom were atopic, were patch-tested with cocamide DEA from 1985 to 1992 using Finn chambers. The patients had been exposed to cocamide DEA during the use of liquid or foam products for handwashing/hand protection while at work. In addition to exposure from these products, one of the patients was exposed to a metalworking fluid containing cocamide DEA. All of the patients had hand dermatitis, and two of the six also had dermatitis on the forearm. The average age of the patients at the onset of dermatitis was 32 years, and the mean duration of dermatitis before diagnosis was 21 months. Before 1989, the patients were tested with cocamide DEA at concentrations ranging from 0.01 to 10%. However, in April of 1989 a commercial test preparation (0.5% cocamide DEA in petrolatum) was used. ... ?+ (doubtful reaction), + (weak, nonvesicular reaction), ++ (strong edematous or vesicular reaction). and +++ (extreme reaction) ... Twenty control patients were tested with a dilution series of cocamide DEA ... One patient was also prick-tested, using a disposable needle, with 0.5% aqueous cocamide DEA on the volar aspect of the forearm. Reactions (wheal and flare) were recorded after 15 to 30 min. The results of product patch tests (six patients) ... were as follows: ++ reactions were observed in the two patients who used hand-protecting foam (100% cocamide DEA), in the patient who used liquid soap (10% cocamide DEA), and in the remaining three patients who used handwashing liquid (10% cocamide DEA). Two of the remaining three also used handwashing liquids with different concentrations of cocamide DEA: one of the two patients had + and ++ reactions to 3% and 20%. Cocamide DEA products, respectively, and the other had a ++ reaction to the 5% cocamide DEA product. The patient who used liquid soap was also patch-tested with metalworking fluid containing cocamide DEA, and the results were: 15% Cocamide DEA, no reaction, 3% Cocamide DEA, + reaction, and 10% Cocamide DEA ++ reaction. Patients patch-tested with cocamide DEA concentrations ranging from 0.1% to 10% in petrolatum had the following reactions: 0.1% Cocamide DEA, + in two of two subjects; 0.2%. ++ in one of one subject: 0.3%. + to +++ in four of four subjects; 0.596, ++ to +++ in three of three subjects; 1%, + to ++ in four of four subjects: 3%. ++ to +++ in two of two subjects; and 10%, ++ to +++ in two of two subjects. All six patients had negative patch-test reactions to 1% aqueous cocamidopropyl betaine. Two of the six also had a negative prick-test reaction to 0.5% aqueous cocamide DEA and a negative patch-test reaction to diethanolamine (0.0001-1%) in petrolatum, respectively. In the group of 20 control patients, there were no reactions to 3% cocamide DEA in petrolatum. and 10 patients had slight irritant reactions to 10% cocamide DEA in petrolatum. It was concluded that cocamide DEA induced occupational allergic contact dermatitis in the six patients who were evaluated.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • HUMAN EXPOSURE STUDIES: The skin irritation potential of six cosmetic-grade surfactant solutions was evaluated using 15 volunteers. One of the solutions consisted of 20% sodium lauryl sulfate and 10% cocamide DEA and another consisted of 20% sodium lauryl sulfate. Two of the remaining solutions also contained 20% sodium lauryl sulfate and another surfactant. In a pilot study, three of the subjects were each patch tested with the six solutions (six semiocclusive patches/subject). Each solution (200 uL) was applied to the external upper arm for 4 hr: sites were rinsed with water after patch removal. Insufficient skin irritation was observed in the pilot study. In the main study, the remaining 12 subjects were patch-tested (occlusive patches) with the six surfactant solutions according to the same procedure. Reactions were scored 1 hr, 24 hr, 48 hr, and 72 hr after patch removal according to the following scale: 0 (no erythema) to 4 (severe erythema). In order to protect against hyperreactivity, a seventh occlusive patch containing 20% sodium lauryl sulfate was applied and removed after 1 hr. According to the investigators, all patches would have been removed if a score >1 was reported; however, none of the subjects reacted adversely. Sodium lauryl sulfate (20% solution) induced erythema in eight subjects. Decreased erythema was noted 1 hr after application of the solution containing 20% sodium lauryl sulfate and 10% cocamide DEA, and complete skin recovery was observed at 48 hr. The remaining four subjects were insensitive to treatment with the surfactants. Based upon the results for the sodium lauryl sulfate/cocamide DEA solution and other surfactant solutions, it was concluded that skin irritation was not related simply to the total concentration of surfactants in contact with the skin, but rather to the combination of surfactants that was present.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • CASE REPORTS: Positive patch-test reactions to handwashing liquids (diluted to 10%) containing cocamide DEA and to 0.5% cocamide DEA have been reported in case studies on dermatitis patients. The patients were exposed to cocamide DEA either in an occupational setting (product use or accidental exposure to fluids) or during product use at home.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • CASE REPORTS: Three cases are reported of individuals allergic to cocamide DEA, also known as coconut diethanolamide. In two cases, multiple other cutaneous allergies were present. In both instances, cocamide DEA was present in several personal care products used by the patients. In the third case, occupational exposure was suspected...[Fowler JF Jr; Am J Contact Dermat 9 (1): 40-1 (1998)] **PEER REVIEWED** <a href="http://www.ncbi.nlm.nih.gov/pubmed/9527440?dopt=Abstract" target=new>PubMed Abstract</a>
  • CASE REPORTS: /The case of/ ... a dentist who got sensitized to several products that have not, or only seldom, caused sensitization earlier /is reported/. These products were: coconut diethanolamide from her handwashing liquids, N-ethyl-4-toluene sulfonamide, a resin carrier in dental materials for isolating cavities underneath restorations, and 4-tolyldiethanolamine, an accelerator for inducing polymerization of dental acrylic resins at room temperature. The patient also had allergic patch test reactions to formaldehyde, phenol-formaldehyde resin, fragrance mix, and lauryl monoethanolamide, possibly from occupational exposure.[Kanerva L et al; Acta Derm Venereol 73 (2): 126-9 (1993)] **PEER REVIEWED** <a href="http://www.ncbi.nlm.nih.gov/pubmed/8103258?dopt=Abstract" target=new>PubMed Abstract</a>
  • CASE REPORTS: Coconut diethanolamide (CDEA), manufactured from coconut oil, is widely used as a surface-active agent in hand gels, hand-washing liquids, shampoos and dish-washing liquids. CDEA has rarely caused allergic contact dermatitis. During 1985-1992, ... 6 patients with occupational allergic contact dermatitis caused by CDEA /were examined/. 2 became sensitized from a barrier cream, 3 from a hand-washing liquid, and 1 had been exposed both to a hand-washing liquid and to a metalworking fluid containing CDEA. Leave-on products (hand-protection foams) caused sensitization much more rapidly (2-3 months) than rinse-off products (hand-washing liquids; 5-7 years). ... No contact allergy to another coconut-oil-derived sensitizer (cocamidopropyl betaine) was found in the patients.[Pinola A et al; Contact Dermatitis 29 (5): 262-5 (1993)] **PEER REVIEWED** <a href="http://www.ncbi.nlm.nih.gov/pubmed/8112067?dopt=Abstract" target=new>PubMed Abstract</a>
  • EPIDEMIOLOGY STUDIES: An epidemiological study was conducted using 284 employees of metalworking factories in the Netherlands. The workers were exposed to metalworking fluids while at work. Dermatitis of the hands and/or forearms was observed in 40 of the 284 workers. The 40 workers were patch-tested with a series of common components of metalworking fluids and preservatives to which the workers had been exposed. Cocamide DEA was patch-tested at a concentration of 0.5% in petrolatum. ... The patches were removed at 48 hr and scored at 72 hr. ... Contact sensitization was observed in eight of the 40 patients; four patients were allergic to biocides and/or corrosion inhibitors. Only one patient had a contact sensitization reaction to 0.5% Cocamide DEA in petrolatum.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • OTHER TOXICITY INFORMATION: Cocamide DEA was classified as a definitive occupational allergen; the ingredient patch-test concentration was not stated. More specifically, it was classified as an occupational allergen in the hairdressing, medical, fitter, food handling, printing, and cleaning groups. Cocamide DEA was responsible for occupational allergic contact dermatitis in 11.5% of the women and 2.3% of the men.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**

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Non-Human Toxicity Excerpts

  • LABORATORY ANIMALS: Acute Exposure: Six rabbits were used to evaluate the irritation of a 30% solution of cocamide DEA in propylene glycol. The dorsal area of each rabbit was shaved and 0.3 mL of the test material was applied via a patch to either an intact or abraded site. The entire trunk of each animal was wrapped in cellophane, and the patches remained in skin contact for 23 hr. Test sites were scored for irritation 1 and 49 hr after patch removal. Thirty percent cocamide DEA was a moderate skin irritant; the primary irritation index (PII) was 3.1 (max 8). No control data ... /was/ available.[Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleanmide DEA, and Oleamide DEA; Journal of American College of Toxicology 5 (5): 415-54 (1986)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Thirty percent cocamide DEA in propylene glycol was tested for ocular irritation in three female rabbits. A single 0.1 mL aliquot of the solution was instilled into the conjunctival sac of the rabbits' left eyes, and the untreated right eyes served as controls. Eyes were examined for irritation and inflammation of the iris, cornea, and conjunctiva 1 hr after instillation and daily thereafter up to a maximum of 7 days. The Draize scoring system for eye irritation was used. Only maximum scores for the one hour and day three readings were reported. The irritation scores for the iris and cornea were 0, and the maximum conjunctival score was 6 at 1 hr and 4 at day 3. All eyes were normal by day 4. The cumulative ocular irritation rating was not reported, but 30% cocamide DEA was at least a mild eye irritant.[Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleanmide DEA, and Oleamide DEA; Journal of American College of Toxicology 5 (5): 415-54 (1986)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: The acute oral toxicity of undiluted cocamide DEA was evaluated in male and female Sprague-Dawley rats. Cocamide DEA in varying amounts was administered to five rats in a single dose by gavage following a 16-hr fast, then the rats were observed for 14 days. Undiluted cocamide DEA was slightly toxic, with an LD50 of 12.2 g/kg and a 95% confidence limit of 10.7 to 14.4 mL/kg. Limit tests on formulations containing either 10 or 12% cocamide DEA were unremarkable.[Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleanmide DEA, and Oleamide DEA; Journal of American College of Toxicology 5 (5): 415-54 (1986)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: The ocular irritation potential of a chemical substance (pH 9-10.5) composed of cocamide DEA (>64%) and diethanolamine (<29%) was evaluated using three New Zealand white rabbits. The chemical was tested at a concentration of 1% according to a modified Draize eye irritation test procedure. Thus, the effective test concentrations of cocamide DEA and diethanolamine were >0.6% and >0.3%, respectively. The test substance (0.1 mL) was instilled into the right conjunctival sac of each rabbit; untreated eyes served as controls. Ocular irritation reactions were scored at 1 hr and 1, 2, 3, 4, and 7 days post-instillation according to the Draize scale: 0-110. The highest mean Draize score (57.67) was reported on day 3. On day 7, a mean Draize score of 37 was reported. It was concluded that the test material was a severe ocular irritant, owing to continued corneal damage in a significant number of rabbits (three of three) through day 7.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: /A solution of coco diethanolamide 78.8%, glycerin 8.6% and diethanolamide 8.3% was/ not sensitizing to guinea pigs in the Buehler test. ... /Coco diethanolamide was also/ not sensitizing to guinea pigs in a maximization test.[European Chemicals Bureau; IUCLID Dataset, Amides, coco, N,N-bis(hydroxyethyl) (68603-42-9) p.37 (2000 CD-ROM edition). Available from, as of July 17, 2008: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Coconut diethanolamide is/ irritating to rabbit skin. ... /When/ applied once daily to the same area of skin and gently massaged into it, /coconut diethanolamide was/ not irritating to /the/ hairless mouse.[European Chemicals Bureau; IUCLID Dataset, Amides, coco, N,N-bis(hydroxyethyl) (68603-42-9) p.34 (2000 CD-ROM edition). Available from, as of July 17, 2008: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
  • LABORATORY ANIMALS: Subchronic or Prechronic Exposure: The subchronic dermal toxicity of cocamide DEA was evaluated using five groups of 10 male and 10 female B6C3F1 mice. The untreated control group also consisted of 10 male and 10 female mice. Initial body weights were not stated; however, body weight gain was reported for experimental and control groups. Group mean body weights were said to have been similar to controls throughout the study. In the five experimental groups, cocamide DEA was applied to the skin for </= 13 consecutive weeks at doses of 50, 100, 200, 400, and 800 mg/kg using dosing solutions (95% ethanol vehicle) at concentrations of 20, 40, 80, 160, or 320 mg/mL, respectively. At the end of the study, the animals were necropsied and tissues processed for histopathological evaluation. There were no deaths in experimental or control groups at any time during the study. Skin irritation at the application site was observed in all males and females of the 800 mg/kg dose group; gross skin lesions were noted in six of 10 males and five of 10 females. The principal microscopic changes in skin were epidermal and sebaceous gland hyperplasia (>/= 50 mg/kg, both sexes), chronic-active inflammation (>/= 200 mg/kg, males; >/= 100 mg/kg, females), parakeratosis (>/= 200 mg/kg, males: >/= 400 mg/kg, females), and ulceration (800 mg/kg, both sexes). Parakeratosis was primarily responsible for the gross changes that were described as "skin crusts" in males and females of the 800 mg/kg dose group. Weight increases in the liver, kidney, and lungs that were seen in experimental groups were considered treatment-related, but they occurred in the absence of pathological changes. Organ weight changes were present in >/= 400 mg/kg dose groups (males) and in >/= 200 mg/kg dose groups (females).[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Subchronic or Prechronic Exposure: The subchronic dermal toxicity of cocamide DEA was evaluated using five groups of 10 male and 10 female Fischer 344 rats. Initial body weights were not stated; however, body weight gain was reported for experimental and control groups. In the five experimental groups, cocamide DEA was applied to the skin for </= 13 consecutive weeks at doses of 25, 50, 100, 200, and 400 mg/kg using dosing solutions (95% ethanol vehicle) at concentrations of 30, 61, 121, 243, and 485 mg/mL, respectively. For clinical pathology evaluations, blood samples were obtained from an additional group of rats (10 males, 10 females) on days 4 and 24; the rats were killed on day 24. Blood samples were also obtained from rats in the control and five dose groups at the end of the study, after which the rats were necropsied and tissues processed for histopathological examination. There were no deaths in experimental or control groups at any time during the study. Group mean body weight depressions of >/= 10% were noted in male rats from the 200 mg/kg dose group and male and female rats from the 400 mg/kg dose group. Skin irritation at the application site was observed in eight females and 10 males from the 200 mg/kg dose group and /in/ all rats from the 400 mg/kg dose group. In the 100 mg/kg dose group, skin irritation was observed in one female and two male rats. The principal microscopic skin changes were epidermal hyperplasia (>/= 25 mg/kg, both sexes), chronic-active inflammation (>/= 100 mg/kg, both sexes), parakeratosis and ulceration (>/= 200 mg/kg, both sexes; 100 mg/kg, males), and sebaceous gland hyperplasia (>/= 100 mg/kg, both sexes; 50 mg/kg, males). Parakeratosis was primarily responsible for the gross changes that were described as "skin crusts". The results of hematological evaluations ... indicated a reduction in hemoglobin concentration in females from the 200 and 400 mg/kg dose groups and in males dosed with 400 mg/kg. A reduction in the hematocrit was noted in females of the three highest dose groups and in males of the 400 mg/kg dose group. Additionally, the red blood cell count was depressed in females of the 200 and 400 mg/kg dose groups. Perturbations in clinical chemistry values for serum albumin, cholesterol, and triglycerides were also observed in some of the dose groups, suggesting that cocamide DEA may have an effect on the biochemical/metabolic functions of the liver. Renal tubule regeneration and renal mineralization were noted in all female dose groups. The severity of renal tubule regeneration was greater in rats of the two highest dose groups (200 and 400 mg/kg) and the severity of renal mineralization was greater in rats of the three highest dose groups (100, 200, and 400 mg/kg). There seemed to be a correlation between dose-related increases (>/=50 mg/kg) in absolute and relative kidney weights in females and cocamide DEA-induced changes in the renal tubule.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • LABORATORY ANIMALS: Subchronic or Prechronic Exposure: /Coconut diethanolamide was admin to/ MuRa Han67 rats by gavage at doses of 0, 70, 250, 750 mg/kg once per day, 5 times/wk for 28 days. The dose of 750 mg/kg was increased after 2 wk ... to 1500 mg/kg ... . All rats survived this dose and the lower doses. No significant gross or microscopic organ injury was seen. Dose related reversible local findings were restricted to the fore stomach mucosa.[European Chemicals Bureau; IUCLID Dataset, Amides, coco, N,N-bis(hydroxyethyl) (68603-42-9) p.38 (2000 CD-ROM edition). Available from, as of July 17, 2008: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
  • LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity: ...There was no evidence of carcinogenic activity of coconut oil acid diethanolamine condensate in male F344/N rats administered 50 or 100 mg/kg /for 104 weeks/. There was equivocal evidence of carcinogenic activity in female F344/N rats based on a marginal increase in the incidences of renal tubule neoplasms. There was clear evidence of carcinogenic activity in male B6C3F1 mice based on increased incidences of hepatic and renal tubule neoplasms and in female B6C3F1 mice based on increased incidences of hepatic neoplasms. These increases were associated with the concentration of free diethanolamine present as a contaminant in the diethanolamine condensate.[DHHS/NTP; Toxicology and Carcinogenesis Studies of Coconut Oil Acid Diethanolamine Condensate (CAS No. 68603-42-9) in F344/N Rats And B6C3F1 Mice (Dermal Studies) (2001) TR-479 NIH Publication No. 01-3969. Available from, as of July 16, 2008: http://ntp.niehs.nih.gov/] **PEER REVIEWED**
  • LABORATORY ANIMALS: Developmental or Reproductive Toxicity: Female Sprague-Dawley rats were admin Comperlan KD by gavage on gestation days 6-15 at doses of 0, 100, 300 and 1000 mg/kg/day. ... No /maternal/ deaths occurred in any dams in the control or treated groups. Compound-related symptoms were observed in all treatment groups as salivation (severe in the 1000 mg/kg/day group) and propulsion of the head. Body weight, body weight gains and corrected body weight gains were comparable across all groups. There were no significant macroscopic findings in any of the control or treated animals. Maternal toxicity NOAEL = 1000 mg/kg/day. ... The sex ratio of the fetuses was not affected by the treatment ... There were no significant differences in the body weights of live fetuses (on a litter or individual basis) between the treated and control groups. ... There were no external macroscopic findings noted in any fetus that were considered to be an effect of the treatment ... . Visceral examinations of the preserved fetuses did not reveal any treatment-related abnormalities. ... Statistically significant retardation in ossification was observed in the 300 and 1000 mg/kg/day groups compared to the controls. The incidence of two sternebrae unossified was significantly increased in the 300 and 1000 mg/kg/day groups compared to the control group. The incidence of incomplete ossification of the skull bones was also significantly increased in the 1000 mg/kg/day group compared to the control group but was essentially due to two dams, which had a total of 10 incomplete ossified skull bones of the 17 observed for this group. The skeletal retardation effects were considered to be incidental because the values were within the normal range of variation for this strain. Developmental toxicity NOAEL: 1000 mg/kg/day /Comperlan KD: amides, coco, N, N-bis(hydroxyethyl) 90-95%/[USEPA/OPPT/HPV CHALLENGE PROGRAM; Appendix 1 of the Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.228 (2004). Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Coconut oil, reaction products with diethanolamine (68603-42-9) as of July 16, 2008.] **PEER REVIEWED**
  • GENOTOXICITY: When cocamide DEA (in ethanol) was tested in L5178Y mouse lymphoma forward mutation assays, both negative and inconclusive results were noted with and without metabolic activation.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • GENOTOXICITY: ...Cocamide DEA in DMSO /induced/ sister chromatid exchanges in Chinese hamster ovary cells with metabolic activation but did not induce chromosomal aberrations with or without metabolic activation. More recent results indicate that cocamide DEA did not induce chromosomal aberrations or sister chromatid exchanges with or without metabolic activation.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**
  • GENOTOXICITY: The mutagenicity of cocamide DEA in dimethyl sulfoxide (DMSO) was evaluated according to a modification of the Ames test procedure using strains TA100 and TA1535 of Salmonella typhimurium. Assays were conducted with and without metabolic activation at doses </= 10,000 ug/plate. Cocamide DEA was not mutagenic in the presence or absence of metabolic activation. Cocamide DEA also was not mutagenic in strains TA97, TA98, TA100, and TA1535 of Salmonella typhimurium when tested, with and without metabolic activation, according to a modification of the same test procedure. Cocamide DEA was tested at doses </= 200 ug/plate.[Cosmetic Ingredient Review; Amended Final Report on the Safety Assessment of Cocamide DEA; Journal of American College of Toxicology 15 (6): 527-42 (1996)] **PEER REVIEWED**

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Human Toxicity Values

  • None found

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Non-Human Toxicity Values

  • LD50 Rat oral 12.2 g/kg /12,200 mg/kg/[European Chemicals Bureau; IUCLID Dataset, Amides, coco, N,N-bis(hydroxyethyl) (68603-42-9) p.32 (2000 CD-ROM edition). Available from, as of July 17, 2008: http://esis.jrc.ec.europa.eu/] **PEER REVIEWED**
  • LD50 Rat (Wistar) oral > 5.0 g/kg /5,000 mg/kg/[USEPA/OPPT/HPV CHALLENGE PROGRAM; Appendix 1 of the Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.169 (2004). Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Coconut oil, reaction products with diethanolamine (68603-42-9) as of July 16, 2008.] **PEER REVIEWED**
  • LD50 Rat (albino) oral > 5.0 g/kg /Carsamide SAC: 95% amides, coco, N, N-bis(hydroxyethyl) & 5% DEA/ /5,000 mg/kg/[USEPA/OPPT/HPV CHALLENGE PROGRAM; Appendix 1 of the Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.171 (2004). Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Coconut oil, reaction products with diethanolamine (68603-42-9) as of July 16, 2008.] **PEER REVIEWED**
  • LD50 Rat (Wistar) oral > 5.0 mL/kg /Monamid 150-ADD/ /5,000 mg/kg/[USEPA/OPPT/HPV CHALLENGE PROGRAM; Appendix 1 of the Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.173 (2004). Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Coconut oil, reaction products with diethanolamine (68603-42-9) as of July 16, 2008.] **PEER REVIEWED**
  • LD50 Rabbit (albino) dermal > 2.0 g/kg /Monamid 150-ADD/ /2,000 mg/kg/[USEPA/OPPT/HPV CHALLENGE PROGRAM; Appendix 1 of the Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.195 (2004). Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Coconut oil, reaction products with diethanolamine (68603-42-9) as of July 16, 2008.] **PEER REVIEWED**

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Absorption, Distribution and Excretion

  • None found

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Metabolism/Metabolites

  • None found

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TSCA Test Submissions

  • None found

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Footnotes

1 Source: the National Library of Medicine's Hazardous Substance Database, 12/12/2012.

The NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.